Multiple Sclerosis (Encephalomyelitis disseminata), G 35, accompanied by severe fatigue G35
Conditions
Interventions
Group 1: Placebo (week 1) - washout (week 2) - active condition (week 3)
during the placebo week, participants use light glasses emitting dim red (660 nm) light at low illumination levels (150 lux) daily upon wakening for 20 minutes
during washout, no light glasses are used
during the active condition, blue-enriched light (468 nm) emitting glasses at higher illumination levels (1500 lux) are worn for 20 minutes upon waking up
Participants are assigned to the study arms (placebo - washout - active vs. active - washout - placebo) in randomized order.
Group 2: Active condition (week 1) - washout (week 2) - placebo (week 3)
Participants are assigned to the study arms (placebo - washout - active vs. active - washout - placebo) in randomized order.
Sponsors
Universitäres Schlafmedizinisches Zentrum Regensburg am Bezirksklinikum Regensburg
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of Multiple Sclerosis Severe suffering from fatigue (score on the Fatigue Severity Scale = 36), compliance and readiness to adhere to the study protocol written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women, Drug or alcohol abuse, Other severe neurological or internistic (comorbid) disorders which could influence the study results, Psychotic symptoms and/or relevant cognitive impairments, Flare-up of MS within the past 6 weeks, Change in MS medication within the past 6 months of study inclusion/planned change of MS medication within study participation, Impairments in motor or sensory functions necessary for participation (writing, filling in app-based questionnaires), Intake of more than one psychoactive substance within the past week which can alter sleep or wakefulness (e.g. amphetamines, metylxanthine, sedatives, hypnotics, antidepressants, antihistamines, neuroleptics, beta-blocker), Excessive smoking (>15 cigarettes/day) Legal guardianship and/or inability to consent, Diseases of the eyes such as retinopathy, retinitis pigmentosa, diabetic retinopathy, macula degeneration, glaucoma, iridozyclitis, Intercontinental travel 6 weeks prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End of 3-week test duration for each participant; Rating of fatigue during the day (VAS_F, Visual Analogue Scale for Fatigue) and during the week (FSS, Fatigue Severity Scale; DFIS, Daily Fatigue Impact scale), daily sleep report regarding the last 24 hours (Sleep Protocol), rating of daily side effects after light glasses usage (Questionnaire on Asthenopic Complaints); rating of quality of life during the week (MQLI, Multicultural Quality of Life Inventory); rating of comfort and acceptance of the light glasses (Acceptance Questionnaire). | — |
Countries
Germany
Contacts
Public ContactJulia Ottersbach
Universitäres Schlafmedizinisches Zentrum Regensburg am Bezirksklinikum
Outcome results
None listed